Effects of Fluoxetine on Cognitive Functioning in Children with Down Syndrome: A Prospective Open-Label Exploratory Study of Safety and Efficacy.
J Child Adolesc PsychopharmacolJun 9, 2026 (epub)
Iris Scala, Carmela Bravaccio, Maria Marino et al.
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In 30 seconds
This phase I open-label study evaluated the safety and efficacy of fluoxetine in 14 children with Down syndrome, aged 6-10 years. Over 12 months, fluoxetine was found to be safe, with no serious adverse events reported. Improvements in visuospatial processing tasks were noted, suggesting potential cognitive benefits from treatment.
Key findings
- No serious or severe adverse events occurred during the study.
- Short-term terminal insomnia was reported in two patients.
- Improvements in visuospatial processing tasks were observed.
- Enhanced expression skills were noted in adaptive behavior assessments.
Why it matters
Understanding the safety and potential cognitive benefits of fluoxetine in children with Down syndrome is crucial for developing effective treatment strategies. This study provides preliminary evidence that may guide future research and clinical practice.